Tissue puncture closure device with actuatable automatic spool driven compaction system

ABSTRACT

A tissue puncture closure device includes an anchor, a sealing plug, a suture coupled to the sealing plug, a compaction arrangement, and an automatic driving assembly. The automatic driving assembly includes first and second spool members and an actuation member. The first spool member is configured to coil a portion of the suture. The second spool member is configured to coil a portion of the compaction arrangement. The actuation member is coupled to the first and second spool members. Activation of the actuation member releases the first spool member for rotation to apply a tension force in the suture, and releases the second spool member for rotation to distally advance a portion of the compaction arrangement to compress the sealing plug.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/773,547, filed on 4 May 2010, now U.S. Pat. No. 8,298,259 B2, whichclaims the benefit of U.S. Provisional Application No. 61/175,737, filed5 May 2009, both of which are hereby incorporated by reference herein intheir entireties.

TECHNICAL FIELD

The present disclosure relates generally to medical devices and moreparticularly to devices for sealing punctures or incisions in a tissuewall.

BACKGROUND

Various surgical procedures are routinely carried out intravascularly orintraluminally. For example, in the treatment of vascular disease, suchas arteriosclerosis, it is a common practice to invade the artery andinsert an instrument (e.g., a balloon or other type of catheter) tocarry out a procedure within the artery. Such procedures usually involvethe percutaneous puncture of the artery so that an insertion sheath maybe placed in the artery and thereafter instruments (e.g., a catheter)may pass through the sheath and to an operative position within theartery. Intravascular and intraluminal procedures unavoidably presentthe problem of stopping the bleeding at the percutaneous puncture afterthe procedure has been completed and after the instruments (and anyinsertion sheaths used therewith) have been removed. Bleeding frompuncture sites, particularly in the case of femoral arterial punctures,may be stopped by utilizing vascular closure devices, such as thosedescribed in U.S. Pat. Nos. 6,090,130 and 6,045,569, which are herebyincorporated in their entireties by this reference.

Typical closure devices such as the ones described in theabove-mentioned patents place a sealing plug at the tissue puncturesite. Successful deployment of the sealing plug, however, typicallyinvolves manually ejecting it from within a device sheath. The sealingplug may also be compacted down to an outer surface of the tissuepuncture using, for example, a compaction member such as a compactiontube. The compaction procedure may commence until the device sheath(within which the compaction tube is located) has been removed so as toexpose the compaction tube for manual grasping. Under certainconditions, removal of the sheath prior to compacting the sealing plugmay cause the sealing plug itself to be displaced proximally from thetissue puncture, hindering subsequent placement of the sealing plug, andresulting in only a partial seal and associated late bleeding from thetissue puncture. Accordingly, there is a need for improving themechanism for deployment of the sealing plug at the site of a tissuepuncture.

SUMMARY

One aspect of the present disclosure relates to a tissue punctureclosure device that includes an anchor, a sealing plug, a suture coupledto the sealing plug, a compaction arrangement, and an automatic drivingassembly. The automatic driving assembly includes first and second spoolmembers and an actuation member. The first spool member is configured tocoil a portion of the suture. The second spool member is configured tocoil a portion of the compaction arrangement. The actuation member iscoupled to the first and second spool members. Activation of theactuation member releases the first spool member for rotation, therebyapplying a tension force in the suture, and releases the second spoolmember for rotation to distally advance a portion of the compactionarrangement to compress or distally advance the sealing plug.

The tissue puncture closure device may also include a housing sized toretain the automatic driving assembly, and the automatic drivingassembly is movable within the housing. The tissue puncture closuredevice may also include an insertion sheath connected to the housing.The compaction arrangement may include a tube portion arranged tocompress the sealing plug, and a coil portion at least partially wrappedabout the second spool member. The tissue puncture closure device mayfurther include a housing sized to retain the automatic drivingassembly, and the actuation member includes an actuation memberaccessible from outside of the housing. The first and second spoolmembers may be operable independent of each other. The actuation membermay be configured to concurrently release the first and second spoolmembers. The actuation member may be configured to restrict rotation ofthe first and second spool members in one direction, and the spoolmembers may be free to rotate in an opposite direction prior to andafter activation of the actuation member.

Another aspect of the present disclosure relates to a tissue punctureclosure device that is adapted for partial insertion into and sealing ofa tissue puncture in an internal tissue wall that is accessible througha percutaneous incision. The device includes an anchor, a sealing plug,a suture, and a compaction arrangement. The anchor is disposed on adistal side of the internal tissue wall. The sealing plug is disposed ona proximal side of the internal tissue wall. The suture is coupled at adistal end portion to the anchor and the sealing plug and is slidablydisposed on the suture proximal of the anchor. The compactionarrangement includes a compaction tube, first and second spool members,and an actuation member. The compaction tube is disposed on the sutureand configured to drive the sealing plug along the suture distallytowards the anchor. The first spool member is configured to have aproximal end portion of the suture wound there about. The second spoolmember is configured to have a portion of the compaction arrangementwound there about. The actuation member is disengageably coupled to thefirst and second spool members, wherein activation of the actuationmember releases the first spool member to rotate to provide a tensionforce in the suture, and releases the second spool member to rotatethereby advancing the compaction member distally to compress or advancethe sealing plug.

The tissue puncture closure device may also include a housing, and thefirst and second spool members are slidable within the housing in adistal direction. The first and second spool members may rotate inopposite directions when released by the actuation member. The first andsecond spool members may be operable independent of each other. Thefirst and second spool members may be arranged non-coaxially relative toeach other. The tissue puncture closure device may further include acarrier tube, and the sealing plug and the compaction tube arepositioned in the carrier tube. The carrier tube may be operativelycoupled to at least one of the first and second spool members, whereinsliding of the first and second spool members within the housing movesthe carrier tube relative to the housing.

A further aspect of the present disclosure relates to a method ofsealing a tissue puncture in an internal tissue wall that is accessiblethrough a percutaneous incision. The method may include providing atissue puncture closure device having an anchor, a sealing plug, asuture coupled to the anchor and sealing plug, a compaction arrangement,first and second spool members, and an actuation member. A portion ofthe suture may be wound about the first spool member, and at least aportion of the compaction arrangement may be wound about the secondspool member. The method may also include inserting the tissue punctureclosure device into the percutaneous incision, deploying the anchor intothe tissue puncture, at least partially withdrawing the closure devicefrom the percutaneous incision, and actuating the actuation member torelease the first and second spool members. Releasing the first andsecond spool members permits rotation of the first spool member therebycreating a tension force in the suture and permitting rotation of thesecond spool member to compress or advance the sealing plug toward theanchor with the compaction arrangement.

The tissue puncture closure device may further include a housing sizedto retain at least the first and second spool members, wherein actuatingthe actuation member includes engaging a portion of the actuation memberthat is exposed outside of the housing. The method may also includeproviding an insertion sheath, and inserting the insertion sheath intothe percutaneous incision may include inserting a portion of the tissuepuncture closure device into the insertion sheath. Deploying the anchormay include advancing the anchor distally beyond a distal end of theinsertion sheath. The method may also include at least partiallywithdrawing the insertion sheath from the percutaneous incision prior toat least partially withdrawing the closure device. The tissue punctureclosure device may further include a carrier tube. The sealing plug maybe positioned in the carrier tube, and withdrawing the tissue punctureclosure device may include at least partially withdrawing the carriertube and compaction arrangement from the percutaneous incision whileleaving the sealing plug positioned in the percutaneous incision.Withdrawing the tissue puncture closure device may include unwinding aportion of the suture from the first spool member, and actuating theactuation member releases the first spool member to wind up a portion ofthe suture.

Additional advantages and novel features will be set forth in thedescription which follows or may be learned by those skilled in the artthrough reading these materials or practicing the examples disclosedherein. The advantages of the invention may be achieved through themeans recited in the attached claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of the presentdisclosure and are a part of the specification. The illustratedembodiments are merely examples and do not limit the scope of theinvention.

FIG. 1 is a partial cut-away view of a tissue puncture closure deviceaccording to the prior art.

FIG. 2 is a side view of the tissue puncture closure device of FIG. 1engaged with an artery according to the prior art.

FIG. 3 is a side view of the tissue puncture closure device of FIG. 1being withdrawn from an artery to deploy a collagen sponge according tothe prior art.

FIG. 4 is a side view of the tissue puncture closure device of FIG. 1illustrating compaction of the collagen sponge according to the priorart.

FIG. 5A is a perspective assembly view of a tissue puncture closuredevice with an automatic compaction or driving mechanism according toone embodiment of the present disclosure.

FIG. 5B is a side view of the tissue puncture closure device of FIG. 5Ainserted into a procedural sheath and shown engaged with an artery in afirst position according to one embodiment of the present disclosure.

FIG. 5C is a detailed inset of FIG. 5B.

FIG. 5D is a side view of the tissue puncture closure device of FIG. 5Ashown engaged with an artery in a second position retracting theprocedural sheath.

FIG. 5E is a detailed inset of FIG. 5D.

FIG. 5F is a side view of the tissue puncture closure device of FIG. 5Ashown engaged with an artery in a third position retracting a carriertube to expose a sealing plug adjacent to the tissue puncture.

FIG. 5G is a detailed inset of FIG. 5F.

FIG. 5H is a side view of the tissue puncture closure device of FIG. 5Ashown engaged with an artery in a fourth position compacting the sealingplug.

FIG. 5I is a detailed inset of FIG. 5H.

Throughout the drawings, identical reference numbers designate similar,but not necessarily identical, elements.

DETAILED DESCRIPTION

As mentioned above, vascular procedures are conducted throughout theworld and require access to a vessel through a puncture. Most often, thevessel is a femoral artery. To close the puncture following completionof the procedure, many times a closure device is used to sandwich thepuncture between an anchor and a sealing plug. However, sometimes thesealing plug is difficult to eject from the closure device and may notproperly seat against an exterior situs of the arteriotomy. If the plugdoes not seat properly against the arteriotomy, there is a potential forprolonged bleeding. The present disclosure describes methods andapparatus that facilitate sealing plug ejection and proper placement ofthe sealing plug.

While the vascular instruments shown and described below includeprocedural sheaths and puncture sealing devices, the application ofprinciples described herein are not limited to the specific devicesshown. The principles described herein may be used with any medicaldevice. Therefore, while the description below is directed primarily toarterial procedures and certain embodiments of a vascular closuredevice, the methods and apparatus are only limited by the appendedclaims.

As used in this specification and the appended claims, the term“compact,” “compacting,” or “compaction” is used broadly to mean anytype of tamping (i.e., packing down by one or a succession of blows ortaps or smooth, steady pressure, but not by excessive force),compacting, or compressing. “Engage” and “engagable” are also usedbroadly to mean interlock, mesh, or contact between two devices.Likewise “disengage” or “disengagable” means to remove or capable ofbeing removed from interlock, mesh, or contact. A “tube” is an elongateddevice with a passageway. The passageway may be enclosed or open (e.g.,a trough). A “lumen” refers to any open space or cavity in a bodilyorgan, especially in a blood vessel. The term “effecting” meansproducing an outcome, achieving a result, or bringing about. The words“including” and “having,” as used in the specification, including theclaims, have the same meaning as the word “comprising.”

Referring now to the drawings, and in particular to FIGS. 1-4, anexample tissue puncture closure device 100 (also referred to as aclosure device or a puncture closure device) is shown. The tissuepuncture closure device includes a carrier tube 102 with a filament orsuture 104 extending at least partially there through. The closuredevice 100 also includes a first or proximal end 106 and a second ordistal end 107. External to a second or distal end 107 of the carriertube 102 is an anchor 108. The anchor may be an elongated, stiff, lowprofile member including an eye 109 formed at the middle. The anchor 108is typically made of a biologically resorbable polymer.

The suture 104 is threaded through the anchor 108 and back to a collagenpad 110. The collagen pad 110 may be comprised of randomly oriented,bound together fibrous material. The collagen pad 110 is slidinglyattached to the suture 104 as the suture passes distally through thecarrier tube 102, but as the suture traverses the anchor 108 andreenters the carrier tube 102, it is securely slip knotted proximal tothe collagen pad 110 to facilitate cinching of the collagen pad 110 whenthe closure device 100 is properly placed and the anchor 108 deployed(see FIG. 4).

The carrier tube 102 typically includes a compaction tube 112 (alsoreferred to herein as a compaction member) disposed therein. Thecompaction tube 112 is slidingly mounted on the suture 104 and may beused by an operator to compact or compress the collagen pad 110 towardthe anchor 108 at an appropriate time to seal a percutaneous tissuepuncture.

Prior to deployment of the anchor 108 within an artery, the eye 109 ofthe anchor 108 rests outside the distal end 107 of the carrier tube 102.The anchor 108 may be temporarily held in place flush with the carriertube 102 by a bypass tube 114 disposed over the distal end 107 of thecarrier tube 102.

The flush arrangement of the anchor 108 and carrier tube 102 allows theanchor 108 to be inserted into a procedural sheath such as insertionsheath 116 as shown in FIGS. 2-4, and eventually through an arterialpuncture 118. The insertion sheath 116 is shown in FIGS. 2-4 insertedthrough a percutaneous incision tract 119 and into an artery 128. Thebypass tube 114 may include an oversized head 120 that prevents thebypass tube 114 from passing through an internal passage of theinsertion sheath 116. Therefore, as the puncture closure device 100 isinserted into the insertion sheath 116, the oversized head 120 bearsagainst a surface 122 of insertion sheath 116. Further insertion of thepuncture closure device 100 results in sliding movement between thecarrier tube 102 and the bypass tube 114, releasing the anchor 108 fromthe bypass tube 114 (see FIG. 1). The anchor 108 remains in the flusharrangement shown in FIG. 1 following release from the bypass tube 114,limited in movement by the insertion sheath 116. The puncture closuredevice 100 is advanced distally until a pair of biased finger lockingmembers 115 of the puncture closure device 100 lockingly engage with ahub member 117 of the insertion sheath (see FIG. 2).

The insertion sheath 116 may include a monofold 124 at a second ordistal end 126 thereof. The monofold 124 acts as a one-way valve to theanchor 108. The monofold 124 is a plastic deformation in a portion ofthe insertion sheath 116 that elastically flexes as the anchor 108 ispushed out through the distal end 126 of the insertion sheath 116. Afterthe anchor 108 passes through the distal end 126 of the insertion sheath116 and enters the artery 128, the anchor 108 is no longer constrainedto the flush arrangement with respect to the carrier tube 102 and itdeploys and rotates to the position shown in FIG. 2.

Referring next to FIGS. 3-4, with the anchor 108 deployed, the closuredevice 100 and the insertion sheath 116 are withdrawn together, ejectingthe collagen pad 110 from the carrier tube 102 into the incision tract119 and exposing the compaction tube 112. With the compaction tube 112fully exposed as shown in FIG. 4, the collagen pad 110 is manuallycompacted, and the anchor 108 and collagen pad 110 are cinched togetherand held in place with the self-tightening slip-knot on the suture 102.The tissue puncture is sandwiched between the anchor 108 and thecollagen pad 110, thereby sealing the tissue puncture 118. The suture104 is then cut and the incision tract 119 may be closed. The suture104, anchor 108, and collagen pad 110 are generally made of resorbablematerials and remain in place while the tissue puncture 118 heals.

Using the typical tissue puncture closure device 100 described above,however, it may be difficult to eject and compact of the collagen pad110. The insertion sheath 116 resists deformation as the collagen pad110 is ejected from the carrier tube and compaction may not commenceuntil the insertion sheath 116 has been removed so as to expose thecompaction tube 112 for manual grasping. Under certain conditions,removal of the insertion sheath 116 prior to compacting the collagen pad110 causes the collagen pad 110 to retract or displace proximally fromthe tissue puncture 118, creating an undesirable gap between thecollagen pad 110 and the tissue puncture 118. The gap may remain evenafter compaction, and sometimes results in only a partial seal andbleeding from the tissue puncture 118.

Therefore, the present specification describes a medical device such asa tissue puncture closure device that is capable of retracting aprocedural sheath relative to a closure device, exposing a distal end ofthe closure device prior to ejecting a sealing plug. The closure devicealso at least partially automatically drives the sealing plug toward atissue puncture upon withdrawal of the tissue puncture closure devicefrom the tissue puncture site. The mechanism for automatically drivingthe sealing plug may be selectably disengagable.

As described above, the general structure and function of tissue closuredevices used for sealing a tissue puncture in an internal tissue wallaccessible through an incision in the skin are well known in the art.Applications of closure devices including those implementing principlesdescribed herein include closure of a percutaneous puncture or incisionin tissue separating two internal portions of a living body, such aspunctures or incisions in blood vessels, ducts or lumens, gall bladders,livers, hearts, etc.

Referring now to FIGS. 5A-I, a medical device, for example a tissuepuncture closure device 200, is shown according to one embodiment of thepresent disclosure. The closure device 200 is shown assembled with aprocedural sheath 216 in FIG. 5A. FIGS. 5B-I illustrate the closuredevice 200 assembled and inserted through the procedural sheath 216 andinto a lumen 232 of a vessel or artery 228. The closure device 200 hasparticular utility when used in connection with intravascularprocedures, such as angiographic dye injection, cardiac catheterization,balloon angioplasty and other types of recanalizing of atheroscleroticarteries, etc. as the closure device 200 is designed to cause immediatehemostasis of the blood vessel (e.g., arterial) puncture. However, itwill be understood that while the description of the embodiments beloware directed to the sealing off of percutaneous punctures in arteries,such devices have much more wide-spread applications and may be used forsealing punctures or incisions in other types of tissue walls as well.Thus, the sealing of a percutaneous puncture in an artery, shown herein,is merely illustrative of one particular use of the closure device 200of the present disclosure.

The closure device 200 includes a first or proximal end portion 206 anda second or distal end portion 207. A carrier tube 202 extends from theproximal end portion 206 to the distal end portion 207 and includes anoutlet 213 (see FIG. 5C) at the distal end portion 207. The distal endportion 207 may include a slit that facilitates easier removal ofcomponents of the closure device 200 from the carrier tube 202.

The carrier tube 202 may be made of plastic or other material and isdesigned for insertion through the procedural sheath 216. The proceduralsheath 216 is designed for insertion through a percutaneous incision 219in a tissue layer 230 and into the lumen 232. The lumen 232 defines aninterior portion of a vessel such as a femoral artery 228. The artery228 includes an artery wall 234.

At the distal end portion 207 of the carrier tube 202 there is an anchor208 and a sealing plug 210. The anchor 208 of the present embodiment istypically an elongated, stiff, low-profile member arranged to be seatedinside the artery 228 against the artery wall 234 contiguous with atissue puncture 218. The anchor 208 is preferably made of a biologicallyresorbable polymer. The anchor 208 may include an eye 209 for connectionto the suture 204. The sealing plug 210 is formed of, for example, acompressible sponge, foam, or fibrous mat made of a non-hemostaticbiologically resorbable material such as collagen. The sealing plug 210may be configured in any shape so as to facilitate sealing the tissuepuncture 218.

The sealing plug 210 and anchor 208 are connected to one another by afilament or suture 204. The suture 204 usually comprises a biologicallyresorbable material. The anchor 208, the sealing plug 210, and thesuture 204 may be collectively referred to as the “closure elements”below. As shown in FIG. 5A, the anchor 208 is initially arrangedadjacent to and exterior of the distal end portion 207 of the carriertube 202, while the sealing plug 210 is initially disposed within thecarrier tube 202. The anchor 208 is shown nested in its low profileconfiguration along the carrier tube 202 to facilitate insertion intothe lumen 232 and deployed with a first surface 236 abutting the arterywall 234 in FIGS. 5B-C.

The suture 204 extends distally from the first end portion 206 of theclosure device 200 through the carrier tube 202. The suture 204 may bethreaded through one or more perforations in the sealing plug 210,through a hole in the anchor 208, and proximally back toward the carriertube 202 to the sealing plug 210. The suture 204 is preferably threadedagain through a perforation or series of perforations in the sealingplug 210. The suture 204 may also be threaded around itself to form aself-tightening slip-knot. The suture 204 may thus connect the anchor208 and the sealing plug 210 in a pulley-like arrangement to cinch theanchor 208 and the sealing plug 210 together when the carrier tube 202is pulled away from the anchor 208 and the sealing plug 210. The anchor208 and the sealing plug 210 sandwich and lock the anchor and plugtogether, sealing the tissue puncture 218.

The carrier tube 202 houses a compaction device, such as a compactiontube 212, for advancing the sealing plug 210 along the suture 204 towardthe anchor 208. The compaction tube 212 may be movable axially relativeto the carrier tube 202. The compaction tube 212 may be part of acompaction arrangement 240 that includes a coiled portion 246 (see FIG.5A) and the compaction tube 212. The compaction arrangement 240 may beconfigured as a single unitary piece. Alternatively, the compactionarrangement 240 may include multiple pieces or segments that areoperatively coupled together.

The compaction tube 212 is shown located partially within the carriertube 202 and proximal of the sealing plug 210. A portion of thecompaction tube 212 may also extend into a handle or housing 236 of theclosure device 200. The compaction tube 212 is preferably an elongatedtubular or semi-tubular rack that may be rigid or flexible and formed ofany suitable material. For example, according to one embodiment, thecompaction tube 212 is made of polyurethane. The suture 204 may extendthrough at least a portion of the compaction tube 212. For example, asshown in FIG. 5A, the suture 204 extends along the compaction tube 212between the first and second end portions 206, 207. However, the suture204 is not directly connected to the compaction tube 212. Accordingly,the suture 204 and the compaction tube 212 may slide past one another.

According to the embodiment of FIGS. 5A-I, the suture 204 attaches to aportion of an automatic driving assembly 242. The automatic drivingassembly 242 includes a first spool member 248, a second spool member250, and a support or slide member 252. The carrier tube 202 may beoperatively coupled to the support member 252. The first and secondspool members 248, 250 may be spring loaded, wherein rotating the firstand second spool members 248, 250 in a first direction “cocks” thespring of the spools and release of the cocked first and second spoolmembers 248, 250 results in automatic rotation in an opposite direction.

The first spool member 248 is arranged in the handle 236 and carried bythe support member 252. The first spool member 248 is configured toretain a coiled portion 205 of the suture 204. The first spool member248 may include a plurality of spool teeth 249 or other contact featuresarranged around a periphery surface thereof that are configured forcontact by features of an actuation member 244.

The second spool member 250 is also arranged in the handle 236 andcarried by the support member 252. The second spool member 250 may beconfigured to retain a coiled portion of a compaction arrangement 240,namely the coiled portion 246 of the compaction arrangement 240. Thesecond spool member 250 may include a plurality of spool teeth 251 orother contact structure arranged around a periphery surface thereof thatare configured for contact by the actuation member 244. Furtherdiscussion concerning the operation of the automatic driving assembly242 is provided below, in particular with reference to FIGS. 5D-I.

The suture 204 and the coiled portion 246 of the compaction arrangement240 are shown in FIG. 5A wrapped about the first and second spoolmembers 248, 250, respectively, in the same clockwise (CW) direction. Inother arrangements, the suture 204 and the coiled portion 246 may bewrapped about the first and second spool members 248, 250, respectively,in opposite directions. A portion of the suture 204 may pass through atensioning member 270. The tensioning member 270 may be configured tomaintain tension in the suture 204 during winding or unwinding of thesuture 204 on the first spool member 248. The tensioning member 270 maybe carried by the support member 252.

The first and second spool members 248, 250 may both be carried by thesupport member 252 of the automatic driving assembly 242. The first andsecond spool members 248, 250 are typically arranged on the supportmember 252 with an axis of rotation A, B of the first and second spoolmembers 248, 250, respectively, being aligned parallel with each other.In some arrangements, such as the one shown in FIGS. 5A-I, the first andsecond spool members 248, 250 are arranged radially spaced apart fromeach other and function independently of each other. In otherarrangements, the first and second spool members are arranged coaxiallywith each other and function independent from each other. In stillfurther arrangements, at least some functionality of the first spoolmember 248 is dependent on functionality of the second spool member 250,or vise versa.

In practice, the carrier tube 202 of the closure device 200 is insertedinto the procedural sheath 216, which is already inserted within theartery 228 (see FIGS. 5B-5C). As the closure device 200 and theassociated closure elements are inserted into the procedural sheath 216,the anchor 208 passes through and out of the distal end of theprocedural sheath 216 and is inserted into the artery lumen 232. Asmentioned above and shown in FIG. 5A, the anchor 208 is initiallyarranged substantially flush with the carrier tube 202 to facilitateinsertion of the anchor 208 through the percutaneous incision 219 andinto the lumen 232.

After the anchor 208 passes out of the distal end of the proceduralsheath 216, however, the anchor 208 tends to deploy or rotate to theposition shown in FIGS. 5B-5C. The closure device 200 may also bepartially withdrawn proximally to catch the anchor 208 on the distal endof the procedural sheath 216 and rotate the anchor 208 to the positionshown in FIGS. 5B-5C. The closure device 200 preferably includes a pairof biased finger locking members 215 (see FIG. 5A) that are lockinglyreceived by a matching pair of recesses in the hub 217 of the proceduralsheath 216. The locking arrangement between the biased finger lockingmembers 215 and matching recesses preferably restricts relative movementbetween the closure device 200 and the procedural sheath 216.

Following deployment of the anchor 208, the handle 236 and theprocedural sheath 216 are withdrawn together. Withdrawing the handle 236causes the anchor 208 to anchor itself within the artery 228 against theartery wall 234. With the anchor 208 anchored within the artery 228 atthe tissue puncture 218, further retraction of the handle 236 andprocedural sheath 216 tends to pull the sealing plug 210 out from thedistal end portion 207 of the carrier tube 202, thereby depositing thesealing plug 210 within the incision or percutaneous incision 219. Theslit (not shown in the figures) in the carrier tube 202 may permit thedistal end portion 207 of the carrier tube to flex or open, facilitatingejection of the sealing plug 210. However, the slit at the distal endportion 207 of the carrier tube 202 may be prevented from opening orflexing by the procedural sheath 216, which is concentric with thecarrier tube 202. Therefore, according to principles of the presentdisclosure, retraction of the handle 236 and procedural sheath 216causes the procedural sheath 216 to retract with respect to the carriertube 202 to a second position shown in FIGS. 5D-5E.

Referring to FIGS. 5D-5E, the distal end portion 207 of the carrier tube202 is exposed within the percutaneous incision 219 as the handle 236and the procedural sheath 216 are retracted proximally in the directionP. The carrier tube 202 retains its position relative to the tissuepuncture 218 until the handle 236 and the procedural sheath 216 havebeen retracted a predetermined distance. Relative movement between thehandle 236/procedural sheath 216 and the carrier tube 202 is facilitatedby a sliding mount arrangement between the automatic driving assembly242 and the handle 236. As discussed above, the support member 252,which carries the first and second spool members 248, 250, is movablerelative to the handle 236. The carrier tube 202 and automatic drivingassembly 242 are mounted, at least in part, to the support member 252.

As shown by a comparison of FIGS. 5A-B with FIG. 5D, the automaticdriving assembly 242, which is attached to the carrier tube 202, isdisplaceable and slides relative to the handle 236 as the handle 236 andprocedural sheath 216 are retracted. FIGS. 5A-B show the support member252, which carries the automatic driving assembly 242, at a distance X₁relative to a front surface 237 of handle 236. FIGS. 5D-E show thesupport member 252 shifted distally to a distance X₂ relative to thefront surface 237. The automatic driving assembly 242 may be initiallyheld in a first position at the distance X₁ relative to a front surface237 of the handle 236 as shown in FIGS. 5A-B. The automatic drivingassembly 242 maintains the first position by contact between a stopsurface 238 of the handle 236 and a stop member 239 that is mounted tothe automatic driving assembly 242. The stop member 239 is configured torelease from the stop surface 238 when a predetermined amount of axialforce is applied to the handle 236 in the proximal direction P. In oneexample, the predetermined amount of axial force is in the range ofabout 0.2 lbs. to about 3.0 lbs., and more preferably in the range ofabout 0.8 lbs. to about 1.5 lbs. FIG. 5D shows the automatic drivingassembly 242 in a second position at the distance X₂ relative to thefront surface 237 of the handle 236.

Retraction of the handle 236 retracts the procedural sheath 216 (whichis fixedly connected to the handle 236), but the automatic drivingassembly 242 and the carrier tube 202 slide relative to the handle 236and therefore remain in a fixed position with respect to the tissuepuncture 218. The automatic driving assembly 242 may slide apredetermined distance with respect to the handle 236 until theautomatic driving assembly 242 reaches a stop surface 238. Thepredetermined distance is preferably at least long enough to at leastpartially expose the slit in the carrier tube 202. Further detailsconcerning sliding movement of a driving assembly in a closure deviceare provided in U.S. Published Patent Application No. 2006/0265006,which is incorporated herein in its entirety by this reference.

When the automatic driving assembly 242 reaches a distal or secondposition in the handle (see FIG. 5D), further retraction of the handle236 withdraws the carrier tube 202 as well, thereby ejecting the sealingplug 210 automatically as shown in FIGS. 5D-E. The handle 236 may befurther retracted after the automatic driving assembly 242 reaches thesecond position (i.e., stop surface 238) by release of some suture slackthat is available in the first spool member 248. The first spool memberrotates in the counter clockwise (CCW) direction to permit release ofthe suture slack. In one example, the amount of suture slack that isavailable is about 0.25 inches to about 1.25 inches, and more preferablyabout 0.7 inches to about 0.9 inches.

Typically, the first spool member 248 is able to rotate in the CCWdirection to permit release of the suture slack, but is held fromrotating in an opposite, clockwise (CW) direction by a first spoolengagement portion 256 of an actuation member 244. The actuation member244 may also be referred to as an actuation member or an actuatormember. In one example, the first spool member 248 may rotate in thefirst rotation direction under about 0.5 lb. to about 3 lbs. of rotationforce or pressure, and more preferably about 1 lbs. to about 2 lbs. ofrotation force. When the suture 204 and compaction coiled portion arewrapped around the first and second spool members 248, 250,respectively, in the same direction, the second spool member 250 istypically held from rotating in the CCW direction by a second spoolengagement portion 258 of the actuation member 244. The second spoolmember 250 may be configured to freely rotate in the CW direction undera predetermined amount of rotation force.

Once the suture slack has been released and the sealing plug 210 hasbeen ejected, the handle 236 and carrier tube 202 are restricted fromfurther retraction relative to the patient. At this point, the operatormay engage an exposed portion 254 (also referred to as an actuatorportion 254) of the actuation member 244. Engaging the actuator portion254 releases the first and second spool engagement portions 256, 258from the spool teeth 249, 251 of the first and second spool members 248,250, respectively.

Upon release from the actuation member 244, the first spool member 248automatically rotates in the CW direction to further wrap the suture 204about the first spool member 248, thereby applying a tension force tothe suture 204 in a proximal direction P. By placing tension on orpulling the suture 204 away from the percutaneous incision 219, thesuture 204 may cinch and lock (with a slip-knot or the like) togetherthe anchor 208 and the sealing plug 210, sandwiching the artery wall 234between the anchor 208 and sealing plug 210.

Upon release from the actuation member 244, the second spool member 250automatically rotates in the CCW direction to unwind the coiled portion246 and advance the compaction tube 212 in the distal direction D.Rotation of the second spool member 250 in the CCW direction provides atorsional motive force that is transduced to a linear compaction forcethrough the coiled portion 246 and the compaction tube 212 to compactthe sealing plug 210 toward the anchor 208. The sealing plug 210 iscompacted while the handle 236 and carrier tube 202 remain in a fixedposition relative to the patient. Compacting the sealing plug 210 mayreduce or eliminate any gaps that may otherwise occur between thesealing plug 210 and the tissue puncture 218 in the artery 228.

The force exerted by the compaction tube 212 and the cinching togetherof the anchor 208 and sealing plug 210 by the suture 204 also causes thesealing plug 210 to deform radially outward within the percutaneousincision 219. The deformed sealing plug 210 may function as an anchor onthe proximal side of the tissue puncture 218 as shown in FIGS. 5H-I.

As the handle 236 of the closure device 200 is retracted from thepercutaneous incision 219, the procedural sheath 216 is concurrentlyretracted (FIGS. 5D-5E). FIGS. 5F-5G show the carrier tube is retractedupon further withdrawal of the handle 236 thereby exposing the sealingplug 210 in the percutaneous incision 219. The sealing plug 210 iscompacted automatically upon release of the first and second spoolmembers 248, 250 by contact with the actuator portion 254 (FIGS. 5H-5I).

After the sealing plug 210 has been sufficiently compacted, theautomatic driving assembly 242 permits further retraction of the closuredevice 200 by unwinding of the first spool member 248 in the CCW withoutadditional compaction. With the closure device 200 (i.e., the compactiontube 212 and the carrier tube 202) retracted from the percutaneousincision 219, the suture 204 is exposed for cutting by the operator toseparate the sealing plug 210 and anchor 208 from the remainder of theclosure device 200.

The preceding description has been presented only to illustrate anddescribe exemplary embodiments of the present disclosure. It is notintended to be exhaustive or to limit the invention to any precise formdisclosed. Many modifications and variations are possible in light ofthe above teaching. It is intended that the scope of the invention bedefined by the following claims.

What is claimed is:
 1. A tissue puncture closure device, comprising: anautomatic driving assembly, comprising: a first spool member; a secondspool member; an actuation member; a suture coupled to the first spoolmember; a compaction member coupled to the second spool member; whereinoperating the actuation member simultaneously releases the first andsecond spool members for rotation to apply tension in the suture andadvance the compaction member, respectively.
 2. The tissue punctureclosure device of claim 1, further comprising a sealing plug, whereinthe compaction member is operable to compact the seal plug whenadvanced.
 3. The tissue puncture closure device of claim 1, furthercomprising an anchor coupled to the suture, wherein the tension in thesuture draws the anchor proximally.
 4. The tissue puncture closuredevice of claim 1, wherein the compaction member at least partiallywraps around the second spool member.
 5. The tissue puncture closuredevice of claim 1, further comprising a housing sized to retain theautomatic driving assembly, and the actuation member is accessible fromoutside of the housing.
 6. The tissue puncture closure device of claim1, wherein the first and second spool members are operable independentof each other.
 7. The tissue puncture closure device of claim 1, whereinan axis of rotation of the first spool member is arranged out ofalignment from an axis of rotation of the second spool member.
 8. Thetissue puncture closure device of claim 1, wherein the actuation memberrestricts rotation of the first and second spool members in onedirection, and the spool members are free to rotate in an oppositedirection prior to and after operation of the actuation member.
 9. Atissue puncture closure device adapted for partial insertion into andsealing of a tissue puncture in an internal tissue wall accessiblethrough a percutaneous incision, the device comprising: a first spoolmember; a second spool member; an anchor disposed on a distal side ofthe internal tissue wall; a suture coupled at a distal end to the anchorand at a proximal end to the first spool member; a sealing plug slidablydisposed on the suture proximal of the anchor; a compaction membercoupled to the second spool member; an actuation member operable torelease the first spool member to wind up the suture, and release thesecond spool member to advance the compaction member to compact thesealing plug toward the anchor.
 10. The tissue puncture closure deviceof claim 9, further comprising a housing, the first and second spoolmembers being slidable within the housing in a distal direction.
 11. Thetissue puncture closure device of claim 9, wherein the first and secondspool members rotate in opposite directions when released by theactuation member.
 12. The tissue puncture closure device of claim 9,wherein the first and second spool members are operable independent ofeach other.
 13. The tissue puncture closure device of claim 9, whereinthe first and second spool members are arranged non-coaxially relativeto each other.
 14. The tissue puncture closure device of claim 10,further comprising a carrier tube, the compaction member beingpositioned in the carrier tube, wherein sliding of the first and secondspool members within the housing moves the carrier tube relative to thehousing.
 15. A method of sealing a tissue puncture, comprising:providing a tissue puncture closure device having a sealing plug, asuture, a compaction member, first and second spool members, and anactuation member, a portion of the suture being wound about the firstspool member, and at least a portion of the compaction arrangement beingwound about the second spool member; advancing the tissue punctureclosure device to the tissue puncture; operating the actuation member torelease the first and second spool members to rotate, wherein the firstspool member creates tension in the suture and the second spool membercompacts the sealing plug to seal the vessel puncture.
 16. The method ofclaim 15, wherein the tissue puncture closure device further includes ahousing sized to retain at least the first and second spool members,wherein operating the actuation member includes moving a portion of theactuation member that is exposed outside of the housing.
 17. The methodof claim 15, further comprising providing an insertion sheath, advancingthe insertion sheath to the vessel puncture, inserting a portion of thetissue puncture closure device into the insertion sheath, and advancingthe sealing plug beyond a distal end of the insertion sheath.
 18. Themethod of claim 15, further comprising providing an anchor coupled tothe suture, positioning the anchor within the vessel, and positioningthe anchor against an inner surface of the vessel with the tensioncreated in the suture.
 19. The method of claim 15, wherein operating theactuation member simultaneously releases the first and second spool torotate.
 20. The method of claim 15, wherein the compaction membercomprises a distal portion being arranged to contact the sealing plugand a proximal portion wrapped around the second spool member.